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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50; DOUBLE MOBILITY HIP SHELL
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MEDACTA INTERNATIONAL SA CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50; DOUBLE MOBILITY HIP SHELL Back to Search Results
Catalog Number 01.32.150MB
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 12/20/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 14 january 2019: lot 174512: (b)(4) items manufactured and released on 07 november 2017.Expiration date: 2022-11-01.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
On dec 18, 2018 we were informed that a patient had pain caused by psoas impingement 1 year and 1 month after primary.On (b)(6) 2018 the surgeon revised the cup, the head and the liner.The surgery was completed successfully.
 
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Brand Name
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
Common Device Name
DOUBLE MOBILITY HIP SHELL
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key8256607
Report Number3005180920-2018-01101
Device Sequence Number1959579
Product Code LPH
UDI-Device Identifier07630030860966
UDI-Public07630030860966
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K143453
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date11/01/2022
Device Catalogue Number01.32.150MB
Device Lot Number174512
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/18/2018
Initial Report FDA Received Date01/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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